Organ Preservation in Early Rectal Cancer Patients

Status Suspended

Clinical Trial Summary

This is a single arm phase II study of neoadjuvant chemotherapy followed by local excision and post-operative chemoradiotherapy in patients with early stage, low rectal adenocarcinoma. After completion of pre-treatment tests/procedures (including pelvic MRI/ERUS; MRI is mandatory at baseline and other imaging is encouraged) and confirmation of eligibility, systemic therapy with FOLFOX will be administered for 12 weeks. 2 to 4 weeks after the chemotherapy, restaging of the primary tumor will be done to evaluate response to therapy (Pelvic MRI and /or sigmoidoscopy). Patients with disease progression or inadequate response to chemotherapy to allow local excision will continue with evaluation and treatment per the current standard of care (chemoradiation followed by TME). These patients will be considered failures for the primary endpoint of the study. Patients who respond to the neoadjuvant chemotherapy will proceed with local excision (open, TEMS or TAMIS), 6-12 weeks after the completion of neoadjuvant chemotherapy, followed by 5-FU based chemoradiotherapy 4-12 weeks after local excision. Patients with positive margins at the time of local excision will also be treated as per standard of care and will be considered as failures. Number of patients who can undergo successful local excision with this approach will define the success of the strategy. After chemoradiation therapy post local excision, patients will be followed closely every 3 months for the first 3 years and then every 2 months for the next 2 years (history/physical, CEA and pelvic MRI). Patients who are deemed failures for the primary end-point will be followed as per standard of care, off-study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03548961
Study type	Interventional
Source	Fox Chase Cancer Center
Contact
Status	Suspended
Phase	Phase 2
Start date	May 11, 2018
Completion date	March 1, 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06380101` - Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)	N/A
Active, not recruiting	`NCT05551052` - CRC Detection Reliable Assessment With Blood
Recruiting	`NCT04323722` - Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	N/A
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04088955` - A Digimed Oncology PharmacoTherapy Registry
Active, not recruiting	`NCT01347697` - Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer	N/A
Recruiting	`NCT04495088` - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer	Phase 3
Withdrawn	`NCT03007771` - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia	Phase 1
Terminated	`NCT01347645` - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer	Phase 1/Phase 2
Not yet recruiting	`NCT03520088` - PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS	N/A
Recruiting	`NCT05556473` - F-Tryptophan PET/CT in Human Cancers	Phase 1
Recruiting	`NCT04749381` - The Role of TCM on ERAS of Rectal Cancer Patients	Phase 2
Enrolling by invitation	`NCT05028192` - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Recruiting	`NCT03283540` - Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Completed	`NCT04534309` - Behavioral Weight Loss Program for Cancer Survivors in Maryland	N/A
Recruiting	`NCT05914766` - An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer	N/A
Recruiting	`NCT04852653` - A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
Recruiting	`NCT03190941` - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients	Phase 1/Phase 2
Terminated	`NCT02933944` - Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer	Phase 1
Completed	`NCT02810652` - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection	N/A