Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

Locally Advanced Rectal Carcinoma Clinical Trial

Official title:

Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05622357
• Other study ID #: 201617097
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2022
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:

• Is total neoadjuvant treatment in this design safe & tolerable?

• Impact of this design on treatment related outcomes in terms of pathological and clinical responses.

Description:

Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 1, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histopathological proof of rectal adenocarcinoma.

• Tumors located within 15 cm and not less than 4 cm from anal verge.

• Age: = 18 years.

• Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).

• ECOG Performance Status: 0-2.

Exclusion Criteria:

• Non-epithelial rectal malignancy such as sarcoma or lymphoma.

• Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.

• Recurrent rectal cancer.

• Previous history of malignancy within the last 5 years.

• Previous pelvic irradiation.

• Psychiatric or addictive disorder that would preclude study therapy.

• Concurrent uncontrolled medical conditions.

• Pregnancy or breast feeding.

• Any contraindication to surgery.

• Extensive peripheral neuropathy.

Related Conditions & MeSH terms

• Locally Advanced Rectal Carcinoma
• Rectal Neoplasms

Intervention

Radiation:
• short course radiation therapy followed by 6 cycles of CAPOX then surgery
Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo	??????

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete response (pCR)	No residual disease in surgical specimen	within 30 days
Primary	clinical complete response(cCR)	No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy	within 30 days
Primary	Sphincter saving surgery	Patients who were deemed abdomino-perineal resection before treatment start & were able to undergo low anterior resection after end of treatment	within 6 months
Secondary	Local control	defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.	3 years
Secondary	Overall survival	defined as period from diagnosis till last follow up or death from any cause	3 years
Secondary	Disease free survival	defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure or distant failure, whichever comes first.	within 3 years