REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation (REDEL)
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|ClinicalTrials.gov Identifier: NCT05902533|
Recruitment Status : Recruiting
First Posted : June 15, 2023
Last Update Posted : August 23, 2023
|Condition or disease||Intervention/treatment||Phase|
|Anal Cancer||Radiation: Radiation (reduced elective nodal dose (30.6 Gy) Drug: Capecitabine Drug: Mitomycin c||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm prospective trial.|
|Masking:||None (Open Label)|
|Official Title:||REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation|
|Actual Study Start Date :||August 14, 2023|
|Estimated Primary Completion Date :||August 14, 2026|
|Estimated Study Completion Date :||August 14, 2029|
Experimental: Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C
Reduced elective nodal dose (30.6 Gy); (28- 30 fractions given M-F for approximately 5.5 to 6 weeks) Capecitabine 825 mg/m2 BID on days with RT Mitomycin C 10 mg/m2 slow IV push Days 1 and 29
Radiation: Radiation (reduced elective nodal dose (30.6 Gy)
28-30 fractions Monday through Friday of intended chemoradiation depending on the total dose required (50.4-54 Gy) which will occur over approximately 5.5 to 6 weeks.
825 mg/m2 BID (Oral Twice daily on days with RT)
Drug: Mitomycin c
10 mg/m2 slow IV push Day 1 and 29
- Assess Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment [ Time Frame: 90 days post treatment ]Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment. In patients treated with IMRT enrolled to NRG/RTOG 0529, the mean GI/GU/Derm/Hem TI was 3.858 (SD=0.892) assessed during this time period with standard nodal dose using a simultaneous integrated boost technique. Thirty-three patients will allow an effect size of 0.4 with 80% power and one-sided alpha of 0.05. This effect size is larger than the difference in toxicity observed compared to the historic standard of 3D-conformal radiation with IMRT (current standard) and thus felt to represent a clinically meaningful difference. The CTCAE Toxicity index will be determined for all Dermatologic, Gastrointestinal, Genitourinary, and hematologic events within 90 days from treatment initiation that are possible, probably, or definitely attributable to treatment.
- Assess patient reported GI toxicity using PRO-CTCAE Diarrhea [ Time Frame: 9 weeks post treatment ]PRO-CTCAE Diarrhea will be used to assess patient reported GI toxicity for the primary endpoint at weeks 3, 5, and 9 (approximately 1-month post-treatment). Any high grade PRO-CTCAE Diarrhea (frequently/almost constantly) in week 3-9 was reported in 71% of patients on a prior trial in this population (UC-GI-1601) with standard nodal dose. With n=33 at alpha =0.05 (actual alpha=0.033) and power=0.80, we can detect a reduction in the proportion of patients reporting any PRO-CTCAE high grade diarrhea (week 3, 5, 9) of at least 22.3%.
- Colostomy-Free-Survival - measured by follow up without colostomy [ Time Frame: 3 years (Patients followed 3 years post Treatment) ]Colostomy-Free-Survival - Time from treatment completion to any colostomy or last follow up without colostomy.
- Disease Free Survival measured by digital rectal exam [ Time Frame: 3 and 6 months post treatment ]Disease Free Survival - Failure to achieve complete response (CR) at 6 months or subsequent recurrence. There will be a documented clinical response assessment of the primary anal tumor primarily by using digital rectal exam at 3 and 6 months to define clinical complete response along with a review of imaging at 6 months. Any residual tumor at 6 months would be considered "failure to achieve a complete response" and would be considered a DFS event. Resolution of the primary tumor after chemoradiation and recurrence of tumor (any size) would be considered a DFS event. Persistence of disease in grossly enlarged lymph node (GTV Gross Nodes) at 6 months or resolution and then recurrence (any size) would be considered DFS event. New lesions in the elective nodal space or any other location will be considered a DFS event.
- Local Regional Recurrence [ Time Frame: 6 months post treatment ]Local Regional Recurrence - All failures within the PTVs for the primary tumor, for the involved Lymph Nodes, or for the Elective Lymph Nodes, including both patients who failed to achieve CR at 6 months and those occurring more than 6 months after completion of chemoradiation after initial CR.
- Overall Survival - measured by survival or death at follow up [ Time Frame: 3 years (Patients followed 3 years post Treatment) ]Overall Survival - Time from registration to death or last follow up
- Proportion of patients requiring a treatment break due to toxicity; measured by more than 3 consecutive fractions missed. [ Time Frame: Measured during the 5.5 - 6 week treatment period ]Treatment breaks- The proportion of patients requiring a treatment break due to toxicity (more than 3 consecutive fractions missed) will be monitored and reported. In RTOG 0529, 50% of patients treated with standard nodal dose required a treatment break.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05902533
|Contact: UCCC Clinical Trials Officefirstname.lastname@example.org|
|Contact: Jordan Kharofa, MDemail@example.com|
|United States, Ohio|
|University of Cincinnati Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45219|
|Contact: Christine Vollmer 513-213-3203 firstname.lastname@example.org|
|Principal Investigator: Jordan Kharofa, MD|