Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial

NCT03690921 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2018-0420NCI-2018-02040
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer. LET-IMPT is a type of radiation therapy that uses high energy proton "beamlets" to "paint" the radiation dose into the target and may help to kill tumor cells and shrink tumors. Giving LET-IMPT and standard chemotherapy may work better in treating patients with anal canal squamous cell cancer.

Conditions

Anal Canal Squamous Cell Carcinoma; Stage I Anal Cancer AJCC v8; Stage II Anal Cancer AJCC v8; Stage IIA Anal Cancer AJCC v8; Stage IIB Anal Cancer AJCC v8; Stage III Anal Cancer AJCC v8; Stage IIIA Anal Cancer AJCC v8; Stage IIIB Anal Cancer AJCC v8; Stage IIIC Anal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity

  Number (percentage) of patients with physician-reported acute G3+ GI, GU and heme toxicities

  Acute physician reported toxicity from start of treatment 12 weeks post-treatment

Secondary Outcomes (5)

• Complete Response at 12 Weeks

  12 weeks

• Local Progression Free Survival at 24 Months

  24 months

• Distant Metastasis-free Survival at 24 Months.

  24 months

• Overall Survival at 24 Months

  24 months

• Complete Response at 24 Weeks

  24 weeks

Study Arms (1)

Treatment (LET-IMPT, chemotherapy)

EXPERIMENTAL

Patients undergo linear energy transfer-optimized intensity modulated proton therapy 5 times per week for 5-6 weeks. Patients also receive standard cisplatin and fluorouracil IV weekly for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Cisplatin; Drug: Fluorouracil; Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Treatment (LET-IMPT, chemotherapy)

Fluorouracil DRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Treatment (LET-IMPT, chemotherapy)

Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy RADIATION

Undergo LET-IMPT

Also known as: LET-Optimized IMPT, LET-Optimized Intensity Modulated Proton Therapy, Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT)

Treatment (LET-IMPT, chemotherapy)

Quality-of-Life Assessment PROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (LET-IMPT, chemotherapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (LET-IMPT, chemotherapy)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-proven, non-metastatic invasive primary squamous cell carcinoma of the anal canal (stages I, II, and III)
• History/physical examination including documentation of the primary anal lesion size, distance from the anal verge and anal sphincter tone within 60 days prior to registration
• Anal examination with biopsy on either colonoscopy, sigmoidoscopy, rigid proctoscopy or anoscopy
• Computed tomography (CT) scan of the chest and abdomen with contrast or contrast-enhanced positron emission tomography (PET)/CT scan within 60 days of registration unless the patient has a documented contrast allergy
• CT scan of pelvis with contrast or contrast-enhanced PET/CT scan within 60 days of registration unless the patient has a documented contrast allergy
• Zubrod performance status of 0-1 within 60 days prior to registration
• Absolute neutrophil count (ANC) \>=1.8 K/ul, cannot be achieved through granulocyte-colony stimulating factor (GCSF) (within 30 days prior to study registration)
• Platelets \>= 100 K/uL, cannot be achieved through transfusion (within 30 days prior to study registration)
• Hemoglobin \>= 8 g/dL, cannot be achieved through transfusion (within 30 days prior to study registration)
• Serum creatinine =\< 1.5 mg/dL (within 30 days prior to study registration)
• Bilirubin =\< 1.4 mg/dL, except in the case of patients with Gilbert's disease (within 30 days prior to study registration)
• White blood cells (WBC) \>= 3000/microliter (within 30 days prior to study registration)
• Aspartate transaminase (AST)/alanine transaminase (ALT) \< 3 x the upper limit of normal (within 30 days prior to study registration)
• International normalized ratio (INR) =\< 1.5 (within 30 days prior to study registration)
• Human Immunodeficiency Virus (HIV) test must be done within 30 days of study registration. If HIV positive, CD4 count must be obtained within 30 days of study registration

You may not qualify if:

• Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years
• Prior systemic chemotherapy for anal cancer
• Prior radiotherapy to the pelvis that would result in overlap of radiation fields
• Evidence of distant metastatic disease (M1)
• Prior surgery to the anal canal that removed all macroscopic anal cancer
• Women of childbearing potential or men who do not agree to use a medically effective form of birth control throughout their participation in the treatment phase of the study
• Severe, active co-morbidity defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; transmural myocardial infarction within the last 6 months; acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; HIV positive with a CD4 count \< 400 cells/mm\^3; other immuno-compromised status; women who are pregnant or lactating; uncontrolled infection as deemed by the principal investigator (PI); patient incarceration

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Fluorouracil; dehydroftorafur; Linear Energy Transfer

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Energy Transfer; Biophysical Phenomena; Physical Phenomena; Biochemical Phenomena; Chemical Phenomena

Results Point of Contact

• Title: Dr. Emma Holliday
• Organization: M D Anderson Cancer Center

EBHolliday@mdanderson.org

713-563-2340

Study Officials

• Emma B Holliday

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 1, 2018
• Study Start: November 8, 2018
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Locations

US (1)